DEVICE: RUSCH (04026704542680)

Device Identifier (DI) Information

RUSCH
IPN051307
In Commercial Distribution
331605
TELEFLEX INCORPORATED
04026704542680
GS1

1
002348191 *Terms of Use
Disposable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Indwelling urethral drainage catheter A sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Commonly known as a Foley catheter, it is intended to be introduced by a healthcare professional. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KOD CATHETER, UROLOGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K850335 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify:
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Clinically Relevant Size

[?]
Size Type Text
Length: 27.5 Inch
Height: 0.1 Inch
Width: 2 Inch
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Device Record Status

c7dcd7b4-f07a-4d70-b470-c2d5e5ae0b19
September 24, 2018
6
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
24026704542684 10 04026704542680 In Commercial Distribution Box
44026704542688 10 24026704542684 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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